The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the health, economic and educational impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). This first phase will be completed in July 2017. The second phase of the study, will quantify the health, economic and educational impact of targeted Pre-Exposure Prophylaxis (PrEP), targeted HIV testing and targeted care interventions in the context of universal treatment and streamlined care. This second phase will be completed in July 2020. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".

To compare the 3 and 6 year cumulative incidence of internally derived HIV infections (infections genetically linked to a prior infection among members of the same community) between the study arms.

Evaluate attitudes of community, patients and providers on care delivery in control and intervention communities [ Time Frame: 3 and 6 years follow up ]

To evaluate attitudes of community, patients and providers on care delivery in control and intervention communities using qualitative focus group interviews

Evaluate implementation of other disease care cascades (hypertension, diabetes, women and children health services) [ Time Frame: 3 and 6 years follow up ]

Uptake of testing, linkage to care and retention to care

Prevalence of complications of diabetes, hypertension and chronic kidney disease (CKD) and to understand the genetic susceptibility of diseases in the study populations. [ Time Frame: 3 and 6 years follow up ]

Number of patients with of complications of diabetes, hypertension and chronic kidney disease (CKD) and to understand the genetic susceptibility of diseases in the study populations in Phase II.

Adherence to PrEP treatment [ Time Frame: 3 years follow up ]

Number of patients who adherence to PrEP treatment

Change in attitudes towards PrEP [ Time Frame: 3 years follow up ]

Qualitative focus group discussions on attitudes toward PrEP

Change in average levels of adults' on- and off-farm employment [ Time Frame: 3 and 6 years follow up ]

To compare the trends in average levels of adults' on- and off-farm employment between the 2 study arms.

Change in average levels of children's on- and off-farm employment [ Time Frame: 3 and 6 years follow up ]

To compare the trends in average levels of children's on- and off-farm employment (child labor) between the 2 study arms.

Change in average levels of children's time allocation to schooling and household activities [ Time Frame: 3 and 6 years follow up ]

To compare the trends in average levels of children's time allocation to schooling and household activities between the 2 study arms.

Change in average asset holdings [ Time Frame: 3 and 6 years follow up ]

To compare the trends in average asset holdings (durable good and livestock) between the 2 study arms.

Change in agricultural output and other economic production [ Time Frame: 3 and 6 years follow up ]

To compare the trends in agricultural output and other economic production, such as fishing, between the 2 study arms.

Change in average levels of cash and in-kind transfers [ Time Frame: 3 and 6 years follow up ]

To compare the trends in average levels of cash and in-kind transfers between the 2 study arms.

Total costs of programming [ Time Frame: 3 and 6 years follow up ]

To compare costs of programming (campaigns, ART) and PrEP (Phase II only) between the study arms: overall; per person identified, linked to care, and started on ART; and per ART-month, CD4 level recovered, and viral load suppressed.

Change in disease burden [ Time Frame: 3 and 6 years follow up ]

To compare disease burden (expressed in disability adjusted life years, DALYs) between the 2 study arms, during and modelled beyond the study period.

HIV and multi-disease testing for all community members at baseline only

Detailed Description:

The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the health, economic and educational impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). This first phase will be completed in July 2017. The second phase of the study, will quantify the health, economic and educational impact of targeted Pre-Exposure Prophylaxis (PrEP), targeted HIV testing and targeted care interventions in the context of universal treatment and streamlined care. This second phase will be completed in July 2020. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk". Primary endpoint for the first and second phase is HIV incidence measured 3 years follow up.

Eligibility

Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Community Level Inclusion Criteria:

Non-adjacent geopolitical units in south-western and eastern Uganda and western Kenya.

Most recent census population between 9,000 and 11,000 individuals.

Served by an ART providing health center.

Community leader commitment for study participation and implementation.

Accessibility to health center via a maintained transportation route.

Community location with sufficient distance from other potential study communities to limit contamination of intervention or control conditions (buffer zone)

Individual Level Inclusion Criteria:

Residency of individual in community, defined as present in household for at least 6 months of the calendar year.

An urban setting defined as a city with a population of 100,000 or more inhabitants.

Absence of a health center able to provide ART.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864603